Group 1 - The 2025 International Lung Cancer Frontier and Innovation Forum was held in Shanghai, focusing on key topics such as clinical prevention and control of lung cancer, breakthroughs in non-small cell lung cancer (NSCLC), and new advancements in immunotherapy for small cell lung cancer (SCLC) [1] - The rise of targeted and immunotherapy has fundamentally reshaped the treatment landscape for lung cancer, with new therapies like antibody-drug conjugates (ADC), bispecific antibodies, T-cell engagers (TCE), and tumor vaccines emerging rapidly [1] - The global incidence of lung cancer remains the highest among malignant tumors, with the company having launched 9 products that benefit over 900,000 patients worldwide, including the first approved PD-1 monoclonal antibody for first-line treatment of SCLC [1] Group 2 - The company's R&D strategy focuses on antibodies and their derivatives, including monoclonal antibodies, bispecific antibodies, multi-specific antibodies, and ADCs, supported by three core technology engines [2] - High-value projects such as HLX3901 and HLX48 are prioritized for future development, while the company continues to build a robust pipeline [2] - Local innovative enterprises have made significant progress over the past decade, providing effective "Chinese solutions" for clinical challenges, emphasizing the need for international collaboration and continuous innovation in tackling lung cancer [2]

Core Viewpoint - Sanofi has granted Pfizer exclusive rights for the development, production, and commercialization of the dual-specific antibody product targeting PD-1 and VEGF, known as project 707, for both human and veterinary uses [1] Group 1: Licensing Agreement - The licensing agreement between Sanofi and Pfizer will officially take effect on July 24, 2025 [1] - The agreement covers all therapeutic, diagnostic, and preventive indications within the licensed area [1] - Payments from Pfizer to Sanofi will be distributed between the company and Shenyang Sanofi [1] Group 2: Clinical Trials - Pfizer has registered two global Phase III clinical trials for the PD-1/VEGF dual antibody PF-08634404 (SSGJ-707) on ClinicalTrials.gov as of October 30, 2025 [1] - The milestone payments outlined in the licensing agreement are contingent upon meeting specific conditions, leading to uncertainty regarding final payments [1]

Core Viewpoint - Sanofi has granted Pfizer exclusive rights for the development, production, and commercialization of the dual-targeting antibody product SSGJ-707, which targets both PD-1 and VEGF, under a licensing agreement that will take effect on July 24, 2025 [1] Group 1: Licensing Agreement Details - The licensing agreement involves a product known as project 707, which is a dual-specific antibody targeting PD-1 and VEGF [1] - All payments made by Pfizer to the licensors will be distributed between the company and Shenyang Sanofi [1] - The agreement includes milestone payments that are contingent upon meeting specific conditions, leading to uncertainty regarding final payments [1] Group 2: Clinical Trials - On October 30, 2025, Pfizer registered two global Phase III clinical trials for the PD-1/VEGF dual antibody PF-08634404 (SSGJ-707) on ClinicalTrials.gov [1]

Core Viewpoint - New Bridge Bio, established in 2016, is a global biotechnology platform company focused on developing innovative precision immuno-oncology drugs for cancer treatment, utilizing a new business model to enhance its drug pipeline through strategic collaborations and specialized subsidiaries [3][4]. Company Overview - New Bridge Bio primarily develops its proprietary drug, givastomig, a bispecific antibody targeting Claudin18.2 and 4-1BB, which is effective against various gastrointestinal malignancies including gastric, esophageal, and pancreatic cancers [3][4]. - The company aims to leverage its new business model to select and advance high-value therapeutic assets through dedicated subsidiaries, enhancing operational focus and risk management [3]. Product Details - Givastomig is designed to target tumors with low Claudin18.2 expression effectively and activates T-cells specifically at the tumor site, potentially reducing systemic side effects associated with traditional therapies [4]. - The global market for first-line treatments for gastric and esophageal adenocarcinoma (GEA), biliary tract cancer (BTC), and pancreatic ductal adenocarcinoma (PDAC) is projected to grow significantly, with estimates of $8.9 billion, $1.8 billion, and $4.4 billion respectively by 2034 [5]. Clinical Development - New Bridge Bio has completed the Phase I clinical study and plans to initiate a randomized Phase II study in early 2026, having received no objections from the FDA regarding its clinical trial plans for givastomig [5]. - The company has established a pipeline that includes three clinical-stage projects, with two focused on oncology and one in ophthalmology [5]. Financial Performance - For the fiscal year 2023, New Bridge Bio reported total revenues of approximately -$202.12 million, with significant operating losses due to high research and administrative expenses [6]. - The company’s revenue from licensing and collaboration was recorded at $632,000 for 2023, with total expenses amounting to $72.65 million [6].

Core Viewpoint - New Bridge Bio has submitted a listing application to the Hong Kong Stock Exchange, with Goldman Sachs and CITIC Securities as joint sponsors [1] Company Overview - New Bridge Bio, established in 2016, is a global biotechnology platform company focusing on developing innovative precision immuno-oncology drugs for cancer treatment [4] - The company aims to enhance its pipeline through strategic collaborations and specialized subsidiaries to better seize market opportunities [4] Product Development - The core product, givastomig, is a novel bispecific antibody targeting Claudin18.2 (CLDN18.2) and T-cell co-stimulatory molecule 4-1BB, applicable to various gastrointestinal malignancies [5] - Givastomig has two main advantages: it can effectively bind to tumors with low CLDN18.2 expression and activates T-cells only after binding to tumor cells, minimizing systemic side effects [5] Market Potential - According to Frost & Sullivan, the global market size for first-line treatments of GEA, BTC, and PDAC (excluding Greater China and South Korea) is estimated at $8.9 billion, $1.8 billion, and $4.4 billion respectively in 2024, projected to reach $13 billion, $2.9 billion, and $6.4 billion by 2034 [7] Clinical Development - New Bridge Bio has completed the safety assessment of the Phase I clinical study and plans to initiate a randomized Phase II study in early 2026 [7] - The company has established a pipeline that includes three clinical-stage projects, with givastomig being a key focus [7] Financial Performance - For the fiscal year ending December 31, 2023, New Bridge Bio reported total revenues of approximately -$202.12 million, with significant operating losses [8] - The company’s total expenses for 2023 were approximately $72.65 million, leading to a substantial operating loss of $72.02 million [8]

的申請版本 香港聯合交易所有限公司與證券及期貨事務監察委員會對本申請版本的內容概不負責，對 其準確性或完整性亦不發表任何意見，並明確表示概不就因本申請版本全部或任何部分內 容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 NovaBridge Biosciences 新橋生物 （根據開曼群島法律註冊成立的有限公司） 警告 本申請版本乃根據香港聯合交易所有限公司（「聯交所」）及證券及期貨事務監察委員會（「證 監會」）的要求而刊發，僅用作提供資料予香港公眾人士。 本申請版本為草擬本，其內所載資料並不完整，亦可能會作出重大變動。閣下閱覽本文件， 即代表閣下知悉、接納並向新橋生物（「本公司」）、其聯席保薦人、整體協調人、顧問或包 銷團成員表示同意： 本公司招股章程根據香港法例第32章公司（清盤及雜項條文）條例送呈香港公司註冊處處長 登記前，本公司不會向香港公眾人士提出要約或邀請。倘於適當時候向香港公眾人士提出 要約或邀請，有意投資者務請僅依據呈交香港公司註冊處註冊的本公司招股章程作出投資 決定；有關文本將於發售期內向公眾刊發。 52791 \ (Project Ion_Redacted) 00b. 警告_Red ...

Core Insights - Roche has entered into a global exclusive collaboration and licensing agreement with Qianxin Biotech for the development, production, and commercialization of QX031N, with a total deal value of up to $1.07 billion [1][2][10] Group 1: Product Overview - QX031N is a long-acting bispecific antibody targeting TSLP and IL-33, proteins involved in respiratory diseases such as COPD and asthma [2][3] - The potential market for QX031N is significant, with nearly 100 million COPD patients in China and an increasing prevalence of asthma, affecting approximately 45.7 million individuals aged 20 and above [3] Group 2: Company Performance - Qianxin Biotech reported a revenue of RMB 206.5 million for the six months ending June 30, 2025, a year-on-year increase of 359.69%, while the loss for the period was reduced by 83.11% to RMB 30.9 million [6][7] - The company has established a leading integrated antibody drug development platform, which supports the efficient discovery and development of differentiated candidate molecules [4] Group 3: Market Position and Future Prospects - The company has one approved product, QX001S, a biosimilar to ustekinumab, and aims to commercialize three self-developed products by 2027 [8][9] - The revenue for the first half of the year was primarily driven by licensing agreements, including upfront payments and milestone fees related to QX030N and QX004N [9]

Core Viewpoint - Company announced a global exclusive collaboration and licensing agreement with F. Hoffmann-La Roche Ltd for the development, production, and commercialization of QX031N, a long-acting bispecific antibody targeting TSLP and IL-33, which are involved in respiratory diseases like COPD and asthma [1] Financial Summary - Company will receive a one-time, non-refundable, and non-deductible upfront payment of $75 million [1] - Company is eligible for up to $995 million in milestone payments related to product development, regulatory approval, and commercialization [1] - Potential future sales will generate tiered royalties for the company [1] Product Overview - QX031N is a research-stage long-acting bispecific antibody targeting TSLP and IL-33 [1] - TSLP and IL-33 are proteins released in response to allergens, viruses, pollution, and mechanical stimuli, playing a significant role in the development of chronic obstructive pulmonary disease (COPD) and asthma [1] - QX031N has the potential to be developed as a treatment option for COPD and asthma, with prospects of being a "First-in-class" and "Best-in-disease" therapy [1]

Core Insights - The company has initiated a Phase II clinical trial for LBL-024, a PD-L1/4-1BB bispecific antibody, for first-line treatment of biliary tract cancer, marking significant progress in expanding the indication for this core product [1] - LBL-024 is the first targeted therapy for 4-1BB receptor to reach the registered clinical stage globally, with potential to become the first approved drug for advanced extra-pulmonary neuroendocrine carcinoma [1] - The drug utilizes the proprietary X-bodyTM platform with an optimal 2:2 structural design, aiming to enhance T-cell activation and synergistically eliminate tumors, showing greater cancer treatment potential compared to PD-1/L1 inhibitors [1] Regulatory Approvals - The company received approval from the National Medical Products Administration (NMPA) in April 2024 to conduct a single-arm registration clinical trial [2] - In October 2024, LBL-024 was granted Breakthrough Therapy Designation (BTD) by NMPA for the treatment of advanced extra-pulmonary neuroendocrine carcinoma [2] - In November 2024, the U.S. Food and Drug Administration (FDA) designated LBL-024 as an Orphan Drug (ODD) for neuroendocrine carcinoma [2]

Investment Rating - The report maintains a rating of "Accumulate" for the company [8]. Core Views - The company is advancing its PD-1/VEGF combination therapy, JS207, which shows significant potential for market leadership and business development opportunities. The drug has demonstrated excellent anti-tumor effects in preclinical studies and is currently undergoing multiple Phase II clinical trials globally [4]. - The core product, Toripalimab, has seen substantial growth in sales, with domestic revenue reaching 954 million yuan in the first half of 2025, a year-on-year increase of approximately 42%. The product has been approved in over 40 countries and regions, including the U.S. and EU, and is the first drug approved by the FDA for nasopharyngeal carcinoma treatment [5]. - The company has a robust pipeline with multiple promising products in development, including JS207 and JS212, which target drug resistance issues. The combination of PD-1/VEGF and ADC therapies presents significant synergistic potential [6]. - A stock incentive plan has been announced, reflecting the company's strong confidence in future performance, with options granted for 25.97 million shares, approximately 2.53% of total shares [6]. Summary by Sections Company Overview - The company, established in December 2012, focuses on discovering, developing, and commercializing innovative therapies. It has a strong drug discovery capability and advanced biotechnological research and development [16]. Management and Pipeline - The management team has extensive experience in the innovative drug sector, with many members having multinational corporation backgrounds. The company has expanded its pipeline to cover three major overseas markets, including PD-1 plus, small nucleic acids, and ADC plus [17][24]. Financial Performance - In the first half of 2025, the company achieved revenue of 1.17 billion yuan, with a compound annual growth rate (CAGR) of 5.13% from 2020 to 2024. The net loss was 410 million yuan, showing significant improvement compared to previous years [28][31]. Commercial Products - Toripalimab is the first domestically approved PD-1 monoclonal antibody, with 12 approved indications in China and ongoing clinical studies for over 15 indications globally. The sales revenue is projected to grow significantly due to expanding indications and international market access [33][37]. Clinical Pipeline - The company has several key products in clinical development, including JS207 and JS212, with promising early data. The ongoing clinical trials are progressing well, with significant patient enrollment [6][7]. International Expansion - The company has established a strong international presence, with Toripalimab approved in multiple countries and regions. The production facility has received GMP certifications, supporting its global commercialization efforts [46][47].